Ultromics Ltd. received U.S. FDA 510(k) clearance for its artificial intelligence-driven decision support tool for the diagnosis of coronary artery disease (CAD). Used in conjunction with a clinician's assessment, Echogo Pro's algorithms improve disease prediction and support more accurate diagnosis. Echogo Pro is a stress-Echo module in the Oxford, U.K.-based company's Echogo suite for CAD diagnosis.
Elixir Medical Corp., reported positive 12-month results for its Dynamx Coronary Bioadaptor System, with no target vessel revascularization (TVR) or stent thrombosis and adaptive remodeling of the artery to sustain healthy blood flow. The findings, from a multisite European trial, were presented during a late-breaking trials session at the PCR e-Course virtual meeting in Paris.
TORONTO – Complain to your doctor about shortness of breath, chest pain or a rapid or irregular heartbeat and chances are you’ll end up on a treadmill to check for the presence of coronary artery disease or CAD. The conventional treadmill stress test is a time-consuming process that could change with patented, AI-driven sensor technology developed by Ottawa, Ontario-based Ausculsciences Inc. and bankrolled by US$10 million from investors anxious to see the CAD-det System approved for sale by the end of the year.
Santa Clara, Calif.-based Shockwave Medical Inc. is working to build its business around the use of intravascular lithotripsy (IVL) in multiple arterial indications. Lithotripsy has been used to destroy kidney stones for decades, but now Shockwave's system is applying that technology to indications including coronary artery disease (CAD), above-the-knee peripheral artery disease (PAD) and below-the-knee PAD that each require a specific catheter.
Pharmaceutical and life sciences giant Bayer AG scored another indication for its MRI contrast agent, Gadavist (gadobutrol) injection, this time in adults with suspected coronary artery disease. The FDA nod makes Gadavist the first and only contrast agent approved for use in cardiac magnetic resonance (CMR) imaging.